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FDA Approves First Single Chain Product for Hemophilia A

industry-newsNote: The below is an edited version of a press release by CSL Behring. The original release can be read in it's entirety here.


KING OF PRUSSIA, Pa., May 26, 2016 — CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved AFSTYLA [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. AFSTYLA is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection from bleeds with two to three times weekly dosing. In clinical trials, patients undergoing prophylaxis with AFSTYLA experienced a median annualized spontaneous bleeding rate (AsBR) of 0.00. Once activated, AFSTYLA is identical to natural factor VIII. Clinical trials of AFSTYLA demonstrated a strong safety profile with no inhibitors observed.

AFSTYLA is indicated in adults and children with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and the perioperative management of bleeding. AFSTYLA is expected to be available early this summer.

 

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